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Worksafe™ Blood Culture Collection Kits: FAN®PLUS Combo
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Worksafe™ Blood Culture Collection Kits: FAN®PLUS Combo FDA UDI
- Generic Name
- Blood culture broth kit IVD FDA UDI
- Device Name
- BacT/ALERT Worksafe Collection Kit contains most of the items to facilitate blood culture collection. This kit contains FA Plus Aerobic and Standard Anaerobic Bottles. FDA UDI
- Model / Reference
- Worksafe™ Blood Culture Collection Kits: FAN®PLUS Combo FDA UDI
- Description
- BacT/ALERT Worksafe Collection Kit contains most of the items to facilitate blood culture collection. This kit contains FA Plus Aerobic and Standard Anaerobic Bottles. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026606473 FDA UDI
- FDA Product Code
- OIB FDA UDI
- GMDN Term
- Blood culture broth kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood culture broth kit IVD
Worksafe™ Blood Culture Collection Kits: FAN®PLUS Combo by Biomerieux , Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood culture broth kit IVD.
- INNOVATE MEDICAL — INNOVATE MEDICAL, LLC · Class II
- INNOVATE MEDICAL — INNOVATE MEDICAL, LLC · Class II
- BD BACTEC™ MGIT™ 960 Supplement Kit — BECTON DICKINSON AND COMPANY · Class I
- Worksafe™ Blood Culture Collection Kits: FAN®PLUS Pediatric — BIOMERIEUX , INC. · Class I
- BACT/ALERT® — BIOMERIEUX , INC. · Class II
- Worksafe™ Blood Culture Collection Kits: FAN®PLUS — BIOMERIEUX , INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biomerieux , Inc.
Sources (1)
- FDA UDI e0490bd8-e759-4673-9377-4a8c723d2989 34 fields · synced May 31, 2026